The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 2304 Century Center Boulevard, Irving, TX, on March 8 through 13, 2012. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation [21, Code of Federal Regulations (CFR) Part 120] In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food Drug and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Accordingly, your lemon and lime juices are adulterated in that they have been prepared packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.Your significant deviations are as follows:

1. You must include in your hazard analysis and HACCP plan control measures that will consistently produce at a minimum, a five-log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, as required by 21 CFR 120.24(a). However, your HACCP plan for ReaLemon 100% Lemon Juice and ReaLime 100% Lime Juice products does not provide controls to ensure a 5-log reduction of the pertinent microorganism, Listeria monocytogenes, in your 100% lemon and lime juices.

We acknowledge that your firm provided our investigator with copies of microbial verification studies that were performed by your firm’s consultant on both juices. Our assessment of the studies revealed that only Salmonella and E. coli O157:H7 were evaluated. The pertinent microorganism in the juice from these concentrates is Listeria monocytogenes. In addition, the study did not evaluate or identify the critical factors necessary for achieving a 5-log reduction (i.e. specific Brix, acidity, temperature, preservatives) and the time of holding necessary for achieving a 5-log reduction.

2. Your hazard analysis and HACCP plan must list the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.7(a) and 120.8(b). However, your HACCP plan for ReaLemon 100% Lemon Juice and ReaLime 100% Lime Juice products does not include the food safety hazards of Listeria monocytogenes as discussed above, metal inclusion due to the (b)(4) processes, or undeclared allergens/food intolerance substances.

With regard to the hazard of undeclared allergens/food intolerances, your ReaLemon and ReaLime 100% juice products contain sodium metabisulfite, a sulfiting agent. Sulfites are known to cause intolerance reactions in sensitive individuals. Sensitive individuals can experience symptoms ranging from mild to life-threatening, including tingling sensations in the mouth, hives, digestive upset, swelling of the tongue and throat, and difficulty in breathing. A declaration of the presence of sulfites in the ingredient declaration is essential to alert sensitive individuals to its presence. While we recognize that your current labels contain such a declaration, there are no ongoing control measures or critical limits in your HACCP plan to assure that the declarations appear in the labels.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).

For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these deviations. You should include with your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Please send your reply to the Food and Drug Administration, Dallas District Office, Attention: Seri Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issue in this letter, please contact Ms. Essary at (214)253-5335.